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Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess - Proposal for a Multicenter Cluster Randomized Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Peritonsillar abscess (PTA) is a collection of pus between the palatine tonsil and the constrictor muscle. PTA is detected by recognizing characteristics during clinical examination: redness, pain, malaise, trismus, and unilateral peritonsillar swelling. Clinical assessment, including inspection and palpation, is the traditional diagnostic method for patients suspected of having PTA. If PTA is suspected, aspiration with a large-gauge needle or incision is performed to drain the abscess . It can be challenging to distinguish PTA and peritonsillar cellulitis (PTC) based on clinical examination alone. Due to the increased availability of point-of-care ultrasound, it is a part of the diagnostic workup of PTA. Several studies have shown that transoral US can improve the diagnostic accuracy of patients with a suspected PTA. However, no large multicenter study has evaluated whether one of these methods is superior to the other. It is therefore very clinician-dependent whether the patient will have a transoral US performed or not. The investigators hypothesize that transoral US will increase the diagnostic accuracy of PTA compared to solely clinical examination, which is a visual and palpatory assessment. This will result in fewer unnecessary aspiration attempts and overlooked PTAs. Additionally, the investigators wish to investigate the number of aspirations of transoral US-guided needle aspirations compared to aspirations without ultrasound. Methods This is a cluster randomized study. Patients with suspected PTA will be randomized 1:1 to groups A and B. The cluster randomization will happen weekly using an online randomization tool. Participants are patients refeered to the outpatient clinic on suspicion of a peritonsillar absces. The primary outcome is the diagnostic accuracy The investigators aim to determine whether transoral US is a standard part of the clinical examination by comparing clinical examinations with and without US.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients referred to the ENT outpatient clinic with a suspected PTA.

• 18 years of age or older.

Locations
Other Locations
Denmark
Department of Otorhinolaryngology, Head and Neck Surgery & Audiolog
RECRUITING
Copenhagen
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, North Zealand Hospital
RECRUITING
Hillerød
Department of ORL - Head & Neck Surgery and Audiology, Zealand University Hospital,
NOT_YET_RECRUITING
Køge
Time Frame
Start Date: 2025-06-09
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 368
Treatments
Experimental: Intervention/clinical investigation with ultrasound
Intervention group~Transoral ultrasound A head and neck surgeon, often an ENT resident, will perform the transoral ultrasound. A hockey stick transducer is used for transoral ultrasound diagnostics. The procedure is performed by placing the transducer in a disposable glove filled with ultrasound gel. Transoral ultrasound is initiated by positioning the transducer on the palatoglossal arch and a cranial to caudal sweep of the tonsil.The affected tonsil and its surroundings are scanned. An abscess will appear as a hypoechoic area between the tonsil and the constrictor muscle or inside the tonsil. There will be no flow in an abscess when Color Doppler is applied. The unaffected tonsil and the surrounding area can be scanned as a reference.~If randomization is with transoral ultrasound, the aspiration attempts can be performed ultrasound-guided.
Active_comparator: Investigation without ultrasound. Control group.
No ultrasound~Standard diagnostic workup and treatment All patients with suspected PTA receive a clinical head and neck examination, including visual inspection of the mouth and throat, and a flexible fiberoptic laryngoscopy (to assess the extent of the abscess in the pharynx and possible edema). If a PTA is suspected, needle aspiration will be performed, followed by relevant antibiotics. Before transoral ultrasound and needle aspiration, a spray of topical anesthetic (lidocaine spray 10 mg/dose) will be applied. In some cases, for example, if the patient has previously had a PTA, an acute tonsillectomy is offered. If the examination does not reveal a PTA, the patients will receive conservative treatment with relevant antibiotics. The patients will be scheduled for a 24-48-hour follow-up if the physician deems it necessary.
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov